The following data is part of a premarket notification filed by E-z Kare Good Health Systems, Inc. with the FDA for E-z Breathers.
Device ID | K953042 |
510k Number | K953042 |
Device Name: | E-Z BREATHERS |
Classification | Dilator, Nasal |
Applicant | E-Z KARE GOOD HEALTH SYSTEMS, INC. P.O. BOX 11 Tavares, FL 32778 |
Contact | Bret Cipes |
Correspondent | Bret Cipes E-Z KARE GOOD HEALTH SYSTEMS, INC. P.O. BOX 11 Tavares, FL 32778 |
Product Code | LWF |
CFR Regulation Number | 874.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-15 |
Decision Date | 1995-12-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
E-Z BREATHERS 75084118 not registered Dead/Abandoned |
EZ Kare Good Health Systems, Inc. 1996-04-05 |